Cleared Traditional

K250679 - FFX Facet Fixation System (FDA 510(k) Clearance)

K250679 · Sc Medica · Orthopedic device
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Dec 2025
Decision
273d
Days
-
Risk

K250679 is an FDA 510(k) clearance for the FFX Facet Fixation System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Sc Medica (Strasbourg, FR). The FDA issued a Cleared decision on December 4, 2025 after a review of 273 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sc Medica devices

Submission Details

510(k) Number K250679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2025
Decision Date December 04, 2025
Days to Decision 273 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 122d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Consultant

Mcra, LLC
Palmer Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 75
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K250679.
DiversiVy™ Facet Screw System
K253432 · Vy Spine, LLC · Mar 2026
Ion-C
K251714 · SurGenTec, LLC · Jan 2026
CORUS-LX Implant
K253190 · Providence Medical Technology, Inc. · Nov 2025
FFX Facet Fixation System
K252153 · Sc Medica · Oct 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · Providence Medical Technology, Inc. · Jul 2025
Arthrex Spine Compression FT Screw
K250920 · Arthrex, Inc. · May 2025